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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034352
Receipt No. R000039157
Scientific Title Effect of daily eating habits on serum phosphorus levels and related metabolic indicators
Date of disclosure of the study information 2018/10/01
Last modified on 2018/10/01

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Basic information
Public title Effect of daily eating habits on serum phosphorus levels and related metabolic indicators
Acronym Effect of daily eating habits on serum phosphorus levels and related metabolic indicators
Scientific Title Effect of daily eating habits on serum phosphorus levels and related metabolic indicators
Scientific Title:Acronym Effect of daily eating habits on serum phosphorus levels and related metabolic indicators
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relationship between habitual diet and blood phosphorus metabolism indicator and elucidate the dietary factors that cause hyperphosphatemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum phosphorus levels
Habitual phosphorus intakes
Key secondary outcomes 24hour renal phosphorus excretion
Serum PTH, FGF23, vitamin D levels
food sources

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
29 years-old >=
Gender Male and Female
Key inclusion criteria Those who received a sufficient explanation of the purpose and contents of the study, who have the capacity to consent, voluntarily volunteer with sufficient understanding, and agree to participate in the document.
Key exclusion criteria 1) Currently, those who have some chronic illness and are undergoing drug treatment.
2) Those who are pregnant, plan for pregnancy during the study period, those who have hope
3) Breastfeeding
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Arai
Organization The University of Shizuoka
Division name Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
Address 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL 054-264-5511
Email arai@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Arai, Masae Sakuma
Organization The University of Shizuoka
Division name Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
Address 52-1 Yada, Suruga-ku, Shizuoka
TEL 054-264-5511
Homepage URL
Email arai@u-shizuoka-ken.ac.jp

Sponsor
Institute The University of Shizuoka
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 浅井内科医院 Asai Clinic
中條医院 Nakajyo Clinc

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 10 Month 01 Day

Other
Other related information cross-sectional study

Management information
Registered date
2018 Year 10 Month 01 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039157

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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